FDA Approves New Stereotactic Radiotherapy System To Treat Early Breast Cancer

Highlights:

• New GammaPod stereotactic delivery system delivers radiotherapy to early breast cancer tissue with a high degree of precision, saving surrounding healthy tissue
• Radiotherapy is currently an important form of treatment for early breast cancer with more than half the patients receiving some form of radiotherapy
• Conventional radiotherapy, while killing cancer cells also damages surrounding healthy tissue with unwanted side effects.

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Novel Treatment for Early Breast Cancer

Novel GammaPod radiotherapy system to deliver radiation to localized area of early breast cancer with accuracy, causing only minimal damage to surrounding normal breast tissue has received the approval of US Food and Drug Administration (FDA). A brainchild of scientists at the University of Maryland School of Medicine (UMSOM), the GammaPod system has been under development for close to a decade. The prototype model was installed and recently tested at the University of Maryland Medical Center (UMMC). 

“With this breast-specific treatment system, we will be able to deliver high-dose radiation to a tumor while minimizing damage to normal breast tissue and even more importantly,to major organs such as the heart and lungs,” says GammaPod co-inventor William F. Regine, MD, FACR, FACRO, the Isadore & Fannie Schneider Foxman Endowed Chair and professor of radiation oncology at the University of Maryland School of Medicine (UMSOM) and chief of radiation oncology at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC).

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How the GammoPod Stereotactic Radiotherapy System Works

Stereotactic radiation therapy, referred to stereotactic body radiation therapy (SRBT) is commonly used to treat brain cancer and cancers in other parts of the body, such as the lung, spine and liver. It is programmed to deliver a high-dose of radiation directly to the cancer tissue, saving adjacent healthy tissue, and requires much lesser treatment sessions in comparison to standard radiation therapy. The GammaPod system allows this same technology to be used to treat early breast cancer.

The machine is so named due to the type of radiation (gamma rays) and the pod-like shape of the device.

The GammaPod system targets the area of tumor with thousands of precisely focused radiation beams from 36 rotating sources. The patient is treated lying stomach down with the breast immobilized by a patented vacuum-assisted cup, which is again locked into the treatment couch. During treatment session, the couch moves while radiation “paints” the tumor. Treatment sessions may last between five minutes to 40 minutes, depending on the plan.

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What Initial Studies of the GammaPod System Show

As part of getting FDA approval, 15 patients were treated with the GammaPod in a feasibility and safety study, starting in early 2016 and the study team at UMSOM submitted the results to the FDA.

Selected patients received a single “boost” treatment with GammaPod to the site where their tumor had been earlier removed surgically, along with three weeks of traditional radiation treatments to the whole breast.

• Results show that the GammaPod system delivers radiation to the tumor site accurately and safely
• The radiation is delivered at maximum dose to tumor area with dose rapidly tapering off outwardly with significantly reduced dose reaching the surrounding healthy tissue
• Total number of sessions was reduced by about three to four sessions

“The GammaPod has the potential to significantly shorten the treatment time to a few sessions or possibly even one treatment,” says inventor Cedric X. Yu, DSc, a clinical professor of radiation oncology at UMSOM and chief executive officer of Xcision Medical Systems, LLC,which he founded in 2006. “We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel. This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”

Following the results of the feasibility and safety study, Xcision Medical Systems, a Columbia, Md.-based company that manufactures the GammaPod, has sought permission from the FDA to begin marketing the GammaPod system to hospitals and other medical facilities this autumn. The FDA granted the company 510(k) clearance in December 2017 paving the way for its use in the clinical setting.

Current Treatment of Early Breast Cancer

With vastly improved diagnosis and screening methods, many breast cancers are diagnosed early while it is confined to localized breast tissue plus/minus regional lymph nodes, before spread to distant sites. Currently, in early breast cancer lesions, the tumor is surgically removed (conserving the breast) along with regional lymph nodes if involved. This will be followed by three to six weeks of radiotherapy as appropriate.

Future Plans

• In future trials, the research team plans to study various ways in which the GammaPod system might be utilized, either before or after surgical treatment
• Determining its efficacy in reducing tumor size before surgery or totally destroying tumor tissue
• Identifying subgroups of patients who might not need surgery following GammaPod therapy

In conclusion, the Gammapod system offers women with early breast cancer the option of precise radiation treatment to shrink and destroy the cancer and may even overcome the need for surgery in some patients at least.

According to Dr. Regine, “We believe this novel radiotherapy system has the potential to change the paradigm for treating early stage tumors, negating the need for surgery for some patients,”

References:

1. FDA clears stereotactic radiotherapy system for use in treating breast cancer - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590313.htm)
2. First Stereotactic Radiation Therapy System Designed to Treat Early Stage Breast Cancer Receives FDA Clearance - (http://www.newswise.com/articles/first-stereotactic-radiation-therapy-system-designed-to-treat-early-stage-breast-cancer-receives-fda-clearance--)

Source-Medindia